Trial Outcomes & Findings for Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years (NCT NCT01073462)
NCT ID: NCT01073462
Last Updated: 2014-07-10
Results Overview
Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).
Recruitment status
COMPLETED
Target enrollment
67 participants
Primary outcome timeframe
Baseline and Months 3, 6, 12, 18, and 24
Results posted on
2014-07-10
Participant Flow
Participant milestones
| Measure |
Paricalcitol IV
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Paricalcitol IV
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Overall Study
Death
|
14
|
|
Overall Study
Kidney transplant
|
10
|
|
Overall Study
Low parathyroid hormone levels
|
8
|
|
Overall Study
Serious adverse event
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
Baseline characteristics by cohort
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
67 participants
n=5 Participants
|
|
Blood Pressure
Systolic
|
137.2 mm Hg
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
Blood Pressure
Diastolic
|
75.1 mm Hg
STANDARD_DEVIATION 11.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 24Population: Intent-to-treat population; last observation carried forward (LOCF) imputation was used.
Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Baseline
|
28.4 percentage of participants
|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Month 3
|
43.3 percentage of participants
|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Month 6
|
35.8 percentage of participants
|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Month 12
|
38.8 percentage of participants
|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Month 18
|
37.3 percentage of participants
|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Month 24
|
35.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 24Population: Intent-to-treat; LOCF was used
Hypercalcemia was defined as a calcium value of \> 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants With Hypercalcemia
Month 24
|
1.5 percentage of participants
|
|
Percentage of Participants With Hypercalcemia
Baseline
|
0.0 percentage of participants
|
|
Percentage of Participants With Hypercalcemia
Month 3
|
0.0 percentage of participants
|
|
Percentage of Participants With Hypercalcemia
Month 6
|
0.0 percentage of participants
|
|
Percentage of Participants With Hypercalcemia
Month 12
|
1.5 percentage of participants
|
|
Percentage of Participants With Hypercalcemia
Month 18
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 24Population: Intent-to-treat; LOCF was used. "n" indicates the number of participants with available data at each time point.
Hyperphosphatemia was defined as a phosphate value of \> 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants With Hyperphosphatemia
Baseline (n=65)
|
0.0 percentage of participants
|
|
Percentage of Participants With Hyperphosphatemia
Month 3 (n=67)
|
28.4 percentage of participants
|
|
Percentage of Participants With Hyperphosphatemia
Month 6 (n=67)
|
31.3 percentage of participants
|
|
Percentage of Participants With Hyperphosphatemia
Month 12 (n=67)
|
25.4 percentage of participants
|
|
Percentage of Participants With Hyperphosphatemia
Month 18 (n=67)
|
23.9 percentage of participants
|
|
Percentage of Participants With Hyperphosphatemia
Month 24 (n=67)
|
22.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 24Population: Intent-to-treat; LOCF was used.
The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Month 3
|
41.8 percentage of participants
|
|
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Month 6
|
40.3 percentage of participants
|
|
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Month 12
|
47.8 percentage of participants
|
|
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Month 18
|
52.2 percentage of participants
|
|
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Month 24
|
47.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Intent-to-treat
The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
|
44.8 percentage of participants
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SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent-to-treat
The percentage of participants with at least one concomitant medication during the course of the study, by the following types: * Phosphate binder * Epoetin * Renin-Angiotensin-Aldosterone System (RAAS) inhibitors * Cinacalcet * Other
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants With at Least One Concomitant Medication
Phosphate binder
|
80.6 percentage of participants
|
|
Percentage of Participants With at Least One Concomitant Medication
Epoetin
|
68.7 percentage of participants
|
|
Percentage of Participants With at Least One Concomitant Medication
RAAS Inhibitor
|
43.3 percentage of participants
|
|
Percentage of Participants With at Least One Concomitant Medication
Cinacalcet
|
13.4 percentage of participants
|
|
Percentage of Participants With at Least One Concomitant Medication
Other
|
86.6 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent-to-treat
The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Percentage of Participants Experiencing Hospitalization
Hospitalizations
|
41.8 percentage of participants
|
|
Percentage of Participants Experiencing Hospitalization
Cardiac-related hospitalizations
|
14.9 percentage of participants
|
|
Percentage of Participants Experiencing Hospitalization
Non-cardiac-related hospitalizations
|
37.3 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3, 6, 12, 18, and 24Population: Intent-to-treat
Cardiac disease progression was determined by the Investigator.
Outcome measures
| Measure |
Paricalcitol IV
n=67 Participants
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
|
|---|---|
|
Number of Participants With Cardiac Disease Progression
Month 3
|
2 participants
|
|
Number of Participants With Cardiac Disease Progression
Month 6
|
2 participants
|
|
Number of Participants With Cardiac Disease Progression
Month 12
|
4 participants
|
|
Number of Participants With Cardiac Disease Progression
Month 18
|
0 participants
|
|
Number of Participants With Cardiac Disease Progression
Month 24
|
0 participants
|
Adverse Events
Paricalcitol IV
Serious events: 31 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paricalcitol IV
n=67 participants at risk
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
4.5%
3/67 • 24 months
|
|
Cardiac disorders
Myocardial infarction
|
4.5%
3/67 • 24 months
|
|
Cardiac disorders
Coronary artery disease
|
3.0%
2/67 • 24 months
|
|
Cardiac disorders
Arrhythmia
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Cardiogenic shock
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Pericarditis
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Sinus bradycardia
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Pneumonia
|
4.5%
3/67 • 24 months
|
|
Infections and infestations
Acute tonsillitis
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Bronchopneumonia
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Cystitis
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Infectious pleural effusion
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Muscle abscess
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Osteomyelitis
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Pancreatic abscess
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Staphylococcal sepsis
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Tracheobronchitis
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/67 • 24 months
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
7.5%
5/67 • 24 months
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
1.5%
1/67 • 24 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.5%
1/67 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.0%
2/67 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
2/67 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/67 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Tooth disorder
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • 24 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
3.0%
2/67 • 24 months
|
|
Nervous system disorders
Carotid artery stenosis
|
1.5%
1/67 • 24 months
|
|
Nervous system disorders
Polyneuropathy
|
1.5%
1/67 • 24 months
|
|
General disorders
Death
|
4.5%
3/67 • 24 months
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.5%
1/67 • 24 months
|
|
Surgical and medical procedures
Medical device implantation
|
1.5%
1/67 • 24 months
|
|
Surgical and medical procedures
Stent placement
|
1.5%
1/67 • 24 months
|
|
Surgical and medical procedures
Surgery
|
1.5%
1/67 • 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
2/67 • 24 months
|
|
Vascular disorders
Hypertensive crisis
|
1.5%
1/67 • 24 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.5%
1/67 • 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/67 • 24 months
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/67 • 24 months
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
1.5%
1/67 • 24 months
|
Other adverse events
| Measure |
Paricalcitol IV
n=67 participants at risk
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
|
|---|---|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
23.9%
16/67 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Pneumonia
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/67 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/67 • 24 months
|
|
Nervous system disorders
Dysgeusia
|
1.5%
1/67 • 24 months
|
|
Nervous system disorders
Headache
|
1.5%
1/67 • 24 months
|
|
Cardiac disorders
Cardiac valve disease
|
1.5%
1/67 • 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/67 • 24 months
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
1.5%
1/67 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.5%
1/67 • 24 months
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER